- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00004421
Deep Brain Stimulation in Treating Patients With Dystonia
Phase II/III Study of Deep Brain Stimulation in Patients With Dystonia
RATIONALE: Dystonia is a disorder in which the muscles that control voluntary movements are persistently or intermittently contracted (not relaxed). Deep brain stimulation is provided by a small, battery operated implant placed under the skin of the chest that delivers low voltage electrical pulses through a wire under the skin that is connected to a specific area of the brain. Deep brain stimulation may help lessen the symptoms of dystonia.
PURPOSE: Phase II/III trial to study the effectiveness of deep brain stimulation in treating patients who have dystonia.
Study Overview
Detailed Description
PROTOCOL OUTLINE: Patients undergo surgery to implant a brain stimulation system consisting of an implanted pulse generator (IPG) in the chest and a wire lead in the globus pallidum internal. After the lead has been implanted, the brain stimulation system is tested. Patients are examined at 1, 3, 6, 9, and 12 months after surgery. A double blinded evaluation, during which the IPG is either off or on, is carried out at 3 and 6 months.
Patients are followed every 3 months as long as the brain stimulation system remains in place.
Completion date provided represents the completion date of the grant per OOPD records
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Locations
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New York
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New York, New York, United States, 10029
- Mount Sinai Medical Center, NY
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics-- Idiopathic or secondary cervical, segmental, or generalized dystonia not adequately controlled with traditional pharmacotherapy and/or botulinum toxin --Prior/Concurrent Therapy-- All medical therapy must be stable within the past month Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: No prior destructive neurosurgical procedure Other: At least 3 months since prior botulinum toxin injections --Patient Characteristics-- Age: 18 to 75 Performance status: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Cardiovascular: No demand cardiac pacemaker Other: No history of substance abuse
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
Investigators
- Study Chair: Mitchell Francis Brin, Icahn School of Medicine at Mount Sinai
Publications and helpful links
General Publications
- Brin MF, Germano I, Danisi FO, et al.: Deep brain stimulation (DBS) of pallidum in intractable dystonia. Movement Disorders 13(suppl 2): 274, 1998.
- Germano IM, Villalobos H, Weisz, et al.: Image-guided computer-assisted technology as adjuvant for placement of deep brain stimulators. Movement Disorders 13(suppl 2): 264, 1998.
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 199/13315
- MTS-FDR001452
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Dystonia
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University of Texas Southwestern Medical CenterMassachusetts General HospitalRecruitingDystonia | Dystonia; Idiopathic | Dystonia, Primary | Dystonia, Secondary | Dystonia, Familial | Dystonia Disorder | Dystonias, Sporadic | Dystonia; Orofacial | Dystonia Lenticularis | Dystonia, Paroxysmal | Dystonia 6 | Dystonia 5 | Dystonia 8 | Dystonia 9 | Dystonia 19 | Dystonia 10 | Dystonia 11 | Dystonia 20 | Dystonia 12 | Dystonia... and other conditionsUnited States
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Fondation Ophtalmologique Adolphe de RothschildCompletedCervical Dystonia, PrimaryFrance
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University Hospital, MontpellierTerminatedSpasticity | Isolated Cervical Dystonia | Complex DystoniaFrance
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National Institute of Neurological Disorders and...Active, not recruitingDystonia | Focal Dystonia | Musician's DystoniaUnited States
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University of FloridaBachmann Strauss Dystonia & Parkinson Foundation, Inc.Completed
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University Hospital, MontpellierTerminatedTardive Dystonia | Generalized Dystonia | Segmental DystoniaFrance
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Duke UniversityAmerican Academy of NeurologyNot yet recruiting
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Institut National de la Santé Et de la Recherche...Assistance Publique - Hôpitaux de ParisNot yet recruiting
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University of Colorado, DenverCompleted
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National Institute of Neurological Disorders and...Completed
Clinical Trials on implanted pulse generator
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Loma Linda UniversityWithdrawnOveractive BladderUnited States
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Hospital General Universitario de ValenciaNot yet recruitingFailed Back Surgery Syndrome | Spinal Cord Stimulation | Genetic ChangeSpain
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University of Alabama at BirminghamNational Institute of Neurological Disorders and Stroke (NINDS)Completed
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Louis Stokes VA Medical CenterUnknownStroke | Spinal Cord Injury | Tetraplegia | Quadriplegia | Partial ParalysisUnited States
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Medtronic Cardiac Rhythm and Heart FailureCompletedBradycardia | PacemakerGermany, Czech Republic, Austria, Sweden, Netherlands, Former Serbia and Montenegro
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UCSF Benioff Children's Hospital OaklandCompletedBasal Cell CarcinomasUnited States
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MetaCure LimitedCompleted
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Abbott Medical DevicesCompleted
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Universidade Federal de Sao CarlosCompleted
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University of LouisvilleCompletedSpinal Cord InjuryUnited States